Tainted heparin has now been implicated in the deaths of 81 U.S. patients, and the Food & Drug Administration (FDA) says it now has made a direct connections between some adverse heparin reactions and the counterfeit ingredient found in some batches of the the drug sourced from China. Now, officials from the U.S. and China are at odds, with each blaming the other country’s manufacturing for problems with the drug. The Chinese are insisting their manufacturing is not to blame for the problems, and claim the defective heparin may have actually originated in the U.S.

According to The New York Times, the FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. The FDA has not determined the original source of all the contamination or the points in the supply chain at which it was added. The Times also said officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February.

Ning Chen, second secretary at the Chinese Embassy, told The Times that, “We don’t have a strong evidence to show that it is heparin or its contaminant that caused the problem.” Chen insisted that heparin reactions had only been seen in the US, indicating that neither the chondroitin sulfate or Chinese manufacturing was at fault.

But Dr. Janet Woodcock, director of the FDA’s drug center, disputed Chen, pointing out that a cluster of heparin reactions had been reported in Germany, and that China had conceded that the drug involved in those reactions was contaminated. She also said the FDA was “fairly confident” that the chondroitin sulfate was capable of causing the adverse heparin reactions seen in the past year.

Baxter International recalled nearly all its heparin injections in the U.S. after some patients experienced extreme – and in some cases fatal – allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Last week, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

This entry was posted on Tuesday, April 22nd, 2008 at 8:49 am and is filed under Pharmaceuticals. You can leave a response, or trackback from your own site.